Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS

Not yet recruiting

• Conditions: Adolescent Idiopathic Scoliosis

• Registration Number: NCT07187271
• Lead Sponsor: Uskudar University

Brief Summary

This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.

Detailed Description

This study aims to compare respiratory parameters (including pulmonary function tests and respiratory muscle strength), aerobic capacity, and sleep quality in individuals aged 12 to 20 years with thoracic adolescent idiopathic scoliosis (AIS), classified as T-type or TL-type based on the ISST classification. The study will be conducted at the Spine Health Center of Acıbadem Maslak Hospital.

A total of 30 volunteer participants will be included. Sagittal plane curvatures will be assessed using EOS imaging, and Cobb angles and axial trunk rotation (ATR) will be recorded. ATR will be measured using a scoliometer during the Adams forward bend test. Demographic data including age, sex, height, weight, and dominant side will also be collected.

Pulmonary function will be assessed using FVC and FEV₁ measurements, while respiratory muscle strength will be evaluated using the Cosmed Pony Fx device to measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Each test will be repeated three times, and the highest value will be used for analysis. Aerobic capacity will be evaluated using a progressive shuttle walk test. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and body image perception will be evaluated using the Scoliosis Appearance Questionnaire.

This is a cross-sectional observational study. Data will be compared between the T-type and TL-type scoliosis groups. The study will be supported by Üsküdar University, and all required devices will be provided by the university.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-05
• Primary Completion: 2025-11-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Individuals with a Cobb angle greater than 10 degrees Adolescents aged 12-20 years diagnosed with thoracic Adolescent Idiopathic Scoliosis, classified as T-type or TL-type according to ISST classification Patients currently undergoing brace treatment

Exclusion Criteria

Individuals with a history of spinal surgery Individuals with neurological disorders Individuals with a diagnosed psychiatric disorder Pregnant individuals Individuals who do not provide consent to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory Muscle Strength (MIP, MEP)	At baseline (single measurement during study enrollment)	Respiratory muscle strength will be assessed using an electronic mouth pressure meter (Cosmed Pony FX, ) by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). This outcome evaluates the strength of inspiratory and expiratory muscles in participants with thoracic and thoracolumbar AIS.

Secondary Outcome Measures

Name	Time	Method
Pulmonary Function (FVC, FEV₁)	At baseline (single measurement during study enrollment)	Pulmonary function will be assessed using an electronic spirometry device (Cosmed Pony FX, ) by measuring Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁). This outcome evaluates respiratory capacity in participants with thoracic and thoracolumbar AIS.
Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)	At baseline (single measurement during study enrollment)	Aerobic capacity will be measured using the Incremental Shuttle Walk Test (ISWT) to determine exercise tolerance and endurance in participants with thoracic and thoracolumbar AIS.
Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)	At baseline (single measurement during study enrollment)	Sleep quality will be evaluated with the validated Turkish version of the Pittsburgh Sleep Quality Index (PUKI). Higher scores indicate poorer sleep quality.
Body Image (Scoliosis Appearance Questionnaire, SAQ)	At baseline (self-administered questionnaire during study enrollment)	Body image perception will be assessed with the Scoliosis Appearance Questionnaire (SAQ) to evaluate patients' perception of spinal deformity.

Trial Locations

Locations (1)

Acıbadem Hospital; Istanbul, Europe & Central Asia - Upper Middle Income, Turkey (Türkiye)